19 results · 23ms · Sources: EU EUDAMED, US FDA

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FlexBoardTM, EagleBoardTM, BreastBoard SXTM

FDA 510(k)
FDA Class 2 ·Radiology

EUROIMMUN EUROLINE PROFILE AUTOIMMUNE LIVER DISEASE 8AG (IGG)

FDA 510(k)
FDA Class 2 ·Immunology

ANTERIOR CERVICAL PLATE SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

CLARIUS ULTRASOUND SCANNER

FDA Adverse Event
Malfunction ·CLARIUS MOBILE HEALTH CORP.·Product code IYN·October 17, 2024

ALENTI

FDA Adverse Event
Malfunction ·ARJOHUNTLEIGH POLSKA SP. ZO.O.·Product code FSA·October 22, 2014

COLLEAGUE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 16, 2011

URETEX TO2 URETHRAL SUPPORT SYSTEM

FDA Adverse Event
Injury ·C.R. BARD, INC. (COVINGTON) -1018233·Product code OTN·May 6, 2013

LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X45 MM

FDA Adverse Event
Malfunction ·STRYKER TRAUMA KIEL·Product code HSB·July 1, 2014

LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X45 MM

FDA Adverse Event
Malfunction ·STRYKER TRAUMA KIEL·Product code HSB·June 30, 2014

LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X45 MM

FDA Adverse Event
Malfunction ·STRYKER TRAUMA KIEL·Product code HSB·June 30, 2014

SHOULDER SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·October 7, 2025

SHOULDER SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·May 5, 2026

GLENOID RECONSTRUCTION SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·October 15, 2025

SHOULDER SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·December 20, 2025

SHOULDER SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·October 22, 2025

GLENOID RECONSTRUCTION SYSTEM

FDA Adverse Event
Malfunction ·MEDACTA INTERNATIONAL SA·Product code PHX·May 26, 2026

SHOULDER SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·October 29, 2024

GLENOID RECONSTRUCTION SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·April 14, 2026

DRX Revolution Mobile X-Ray System

FDA Enforcement
Class II ·Ongoing·Carestream Health, Inc.·December 13, 2023